Pradaxa – pro

Dabigatran (Pradaxa ) is an oral anticoagulant from the class of the direct thrombin inhibitors. It is oral and offers an alternative to warfarin. Unlike warfarin(Coumadin) it does not require frequent blood tests for international normalized ratio (INR) monitoring while offering similar results in terms of efficacy. On the other hand, there is no specific way to reverse the anticoagulant effect of dabigatran in the event of a major bleeding event, unlike warfarin. The U.S. Food and Drug Administration (FDA) approved Pradaxa on October 19, 2010, for prevention of stroke in patients with non-valvular atrial fibrillation. On December 7, 2011, the FDA initiated an investigation into serious bleeding events associated with dabigatran stating that the “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa [RE-LY trial].”

In May 2012, the Institute for Safe Medication Practices released its “Quarterwatch” report reviewing data from the third and fourth quarters of 2011. They concluded that Pradaxa had the most reports of serious, disabling, and fatal events, accounting for 3,781 domestic reports overall in 2011, including 542 patient deaths. It surpassed all other regularly monitored drugs in reports of hemorrhage, acute renal failure, and stroke.

Warfarin, on the other hand, accounted for 1,106 cases overall in 2011, including 72 deaths.

It is far from clear that it is better alternative than older anti-coagulants in the settings of chemotherapy of stem cell transplantation.

Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M, ES; Kamphuisen, PW; Sijpkens, MK; Meijers, JC; Buller, HR; Levi, M (2011-10-04). “Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects”. Circulation 124 (14): 1573–9.

^ van Ryn J, Stangier J, Haertter S, et al. (2010 Jun). “Dabigatran etexilate–a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity”. Thrombosis and Haemostasis 103 (6): 1116–27.

R. Romanelli et al, Dabigatran Versus Warfarin for Atrial Fibrillation in Real-World Clinical Practice
A Systematic Review and Meta-Analysis. Circulation 2020 2016;9:126134

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